IGF::OT::IGF PILOT STUDY TO DETERMINE FEASIBILITY OF OBTAINING PATIENT REPORTED OUTCOMES FROM CANCER SURVIVORS TO ENHANCE SEER REGISTRIES. PERIOD PF PERFORMANCE SEPTEMBER 19, 2016 - SEPTEMBER 18, 2017

IGF::OT::IGF 试点研究，以确定从癌症幸存者那里获取患者报告结果以加强 SEER 登记的可行性。

• 批准号: 9361248
• 负责人: THERESA HASTERT
• 金额: $ 14.76万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-19 至 2017-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9361248
• 关键词: Blood specimen; Cancer Survivor; Clinical; Clinical Trials; Collection; Consent; Data Collection; Elderly; Future; Health Personnel; Institutional Review Boards; Investigation; Long-Term Effects; Malignant Neoplasms; Medical Records; Methods; Minority; Mission; Newly Diagnosed; Outcome; Patient Outcomes Assessments; Patient Self-Report; Patients; Performance; Pilot Projects; Process; Protocols documentation; Questionnaires; Recruitment Activity; Registries; Resources; SEER Program; Specimen; Vulnerable Populations; base; improved; neoplasm registry; novel therapeutics; psychologic; social; tumor; willingness

Cancer survivors often deal with a myriad of physical, psychological, financial and social consequences, some predictable and others unknown. Information on long-term effects of new therapies is sparse, especially for vulnerable populations under-represented in clinical trials such as the elderly, minorities, and those with multiple co-morbid conditions. The proposed pilot study will develop methods to enhance cancer surveillance through the SEER registries by exploring the opportunity to use cancer registries as a base that will support collection of broader information, consistent with the mission of the NCI and the SEER Program, to support investigations into how to improve clinical cancer outcomes. The objectives of this study are: 1) Collaborate with NCI staff in developing a common protocol and questionnaires to identify, contact and assess the patient's willingness to provide information and to participate in future investigations, 2) Define barriers and challenges related to contacting patients and obtaining self-reported information and consent to access medical records, 3) Assess the process of identifying, contacting, recruiting and consenting newly diagnosed patients who are undergoing treatment and cancer survivors to provide additional information to support future registry data collection, including requirements of institutional review boards (IRB) and methods of contact (e.g., direct contact or via health care provider), 4) Assess the willingness of patients in cancer registries to allow access to medical records and tumor specimens, and potentially contribute other biospecimens such as blood samples; and identify resources needed to accomplish these tasks.

癌症幸存者经常要面对无数的身体、心理、经济和社会后果，有些是可以预见的，有些是未知的。关于新疗法长期效果的信息很少，特别是对于临床试验中代表性不足的弱势群体，例如老年人、少数族裔和患有多种共存疾病的人。拟议的试点研究将开发通过 SEER 登记处加强癌症监测的方法，探索利用癌症登记处作为基础的机会，支持收集更广泛的信息，这与 NCI 和 SEER 计划的使命一致，以支持对癌症的调查如何改善临床癌症结果。本研究的目标是：1) 与 NCI 工作人员合作制定通用方案和调查问卷，以识别、联系和评估患者提供信息和参与未来调查的意愿，2) 明确与联系患者和患者相关的障碍和挑战，获取自我报告的信息并同意访问医疗记录，3) 评估识别、联系、招募和同意新诊断的正在接受治疗的患者和癌症幸存者的过程，以提供更多信息来支持未来的登记数据收集，包括机构审查委员会 (IRB) 的要求和联系方法（例如，直接联系或通过医疗保健提供者），4) 评估癌症登记处患者允许获取医疗记录和肿瘤样本的意愿，并可能提供其他生物样本，例如作为血液样本；并确定完成这些任务所需的资源。